gima vital-snet monitor

gima vital-snet monitor
PROFESSIONAL MEDICAL PRODUCTS
Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 fax +39 08 95380056
[email protected] - [email protected]
www.gimaitaly.com
GIMA VITAL-SNET MONITOR
M35122-M-Rev.0.05.11
User Manual
ATTENTION: The operators must carefully read and completely understand
the present manual before using the product
z
0123
Fabbricante/Manufacturer:
Shenzhen Creative Industry Co., Ltd. 2/F Block 3 Nanyou Tian’an Industry Town
518054 Shenzhen, GD - P.R.C.
Shanghai International Trading Corp. GmbH (Hamburg)
Eiffestrasse 80, 20537 Hamburg - Germany
This Manual is written and compiled in accordance with the IEC 60601-1Medical electrical
equipment Part1: General requirements for safetyand MDD 93/42/EEC. It complies with both
international and enterprise standards and is also approved by State Technological Supervision
Bureau. The Manual is written for the current PC-900 Vital Signs Monitor.
The Manual describes, in accordance with the Vital Signs Monitor’s features and requirements,
main structure, functions, specifications, correct methods for transportation, installation, usage,
operation, repair, maintenance and storage, etc. as well as the safety procedures to protect both
the user and equipment. Refer to the respective chapters for details.
The Manual is published in English and we have the ultimate right to explain the Manual.
Version of This Manual: Ver1.0
December 25, 2009
Copyright © 2009 Shenzhen Creative Industry Co., Ltd.
All rights reserved.
Marks in the Manual:
Warning: must be followed to avoid endangering the operator and the
patient.
Attention: must be followed to avoid causing damage to the monitor.
Note: some important information and tips about operations and
application.
-I-
Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following
information very carefully before using this device.
Read these instructions carefully before using this monitor. These instructions
describe the operating procedures to be followed strictly. Failure to follow these
instructions can cause monitoring abnormity, equipment damage and personal
injury. The manufacturer is NOT responsible for the safety, reliability and
performance issues and any monitoring abnormality, personal injury and
equipment damage due to user’s negligence of the operation instructions. The
manufacturer’s warranty service does not cover such faults.
Do not use this device in an environment with ignitable or inflammable gas.
Do not place the monitor in any position that may cause it to fall on the
patient.
Check the safety and performance of this monitor every time before using
it to ensure it works normally and safely
Ensure the monitor is grounded reliably before using it, if the integrity of
grounding connection is in doubt, the monitor should work by using the
built-in battery.
Equipment connected with this monitor should be IEC 60601-1 complied.
Turn off the monitor and take away the sensors from the patient during
MRI scanning. Otherwise it may cause burn to the patient and the quality
of MRI image or the measurement accuracy of the monitor may be
affected.
Although biocompatibility tests had been done to all the applied parts,
some exceptional allergic patients may still have anaphylaxis. Do NOT
apply to those who suffer from anaphylaxis.
All the cables and hoses of the applied parts should be kept away from the
patient’s neck to prevent any possible choke of the patient.
All the parts of the monitor should NOT be replaced at will. If necessary,
please use the components provided by the manufacturer or those of the
same model and standards as the accessories along with the monitor
which are provided by the same factory, otherwise negative effects
concerning safety and biocompatibility, etc. may be caused.
If the monitor falls off accidentally, please do NOT operate it until its safety
and performance have been carefully tested and positive testing results
-II-
obtained.
Dispose of the device and its accessories, the local law should be followed.
-III-
Table of Contents
CHAPTER 1 OVERVIEW ................................................................................................. 1
1.1 F EATURES ....................................................................................................................................... 1
1.2 PRODUCT NAME AND MODEL ........................................................................................................... 1
1.3 INTENDED USE ................................................................................................................................ 1
1.4 CONFORMATION .............................................................................................................................. 1
1.5 SYMBOLS ON THE MONITOR ............................................................................................................. 2
CHAPTER 2 OPERATING PRINCIPLE........................................................................... 3
2.1 O VERALL STRUCTURE ...................................................................................................................... 3
CHAPTER 3 INSTALLATION AND CONNECTION........................................................ 4
3.1 APPEARANCE .................................................................................................................................. 4
3.1.1 Front Panel............................................................................................................................. 4
3.1.2 Side Panel .............................................................................................................................. 6
3.1.3 Rear Panel.............................................................................................................................. 7
3.2 INSTALLATION.................................................................................................................................. 8
3.2.1 Opening the Package and Check.......................................................................................... 8
3.2.2 Connecting the Power Supply............................................................................................... 8
3.2.3 Starting the Monitor ............................................................................................................... 8
3.3 SENSOR PLACEMENT AND CONNECTION ........................................................................................... 9
3.3.1 ECG Cable Connection ......................................................................................................... 9
3.3.2 Blood Pressure Cuff Connection......................................................................................... 11
3.3.3 SpO2 Sensor Connection..................................................................................................... 12
3.3.4 TEMP Transducer Connection ............................................................................................ 13
3.3.5 Loading printing paper ........................................................................................................ 13
3.3.6 Battery Installation ............................................................................................................... 15
CHAPTER 4 OPERATIONS .......................................................................................... 16
4.1 INITIAL MONITORING SCREEN ......................................................................................................... 16
4.1.1 Default Display Screen Description ..................................................................................... 17
4.1.2 Operation Instructions ......................................................................................................... 17
4.2 SPO 2 MONITORING SCREEN........................................................................................................... 18
4.2.1 Screen Description .............................................................................................................. 18
4.2.2 Operation Instructions ......................................................................................................... 19
4.3 TREND GRAPH DISPLAY ................................................................................................................. 19
4.3.1 Screen Description .............................................................................................................. 19
4.3.2 Operation Instructions ......................................................................................................... 20
4.4 NIBP LIST SCREEN ....................................................................................................................... 20
4.4.1 Operation Instructions ......................................................................................................... 21
-IV-
4.5 SETUP MENU SCREEN ................................................................................................................... 21
4.5.1 ECG and Temperature Setup .............................................................................................. 22
4.5.2 SpO2 Setup .......................................................................................................................... 23
4.5.3 NIBP Setup .......................................................................................................................... 24
4.5.4 Nurse Call............................................................................................................................. 25
4.5.5 System Setup....................................................................................................................... 26
4.5.6 Patient Info ........................................................................................................................... 27
4.5.7 Date/Time............................................................................................................................. 27
4.5.8 Recover Default Settings ..................................................................................................... 27
4.6 POWER SAVING MODE ................................................................................................................... 28
CHAPTER 5 TECHNICAL SPECIFICATIONS .............................................................. 28
5.1 ECG MONITORING ........................................................................................................................ 28
5.2 TEMP MONITORING ...................................................................................................................... 29
5.3 NIBP MONITORING ....................................................................................................................... 29
5.4 SPO 2 MONITORING ........................................................................................................................ 29
5.5 PULSE MONITORING ...................................................................................................................... 29
5.6 DATA RECORDING ......................................................................................................................... 30
5.7 OTHER T ECHNICAL SPECIFICATIONS ............................................................................................... 30
5.8 OPERATING ENVIRONMENT............................................................................................................. 30
5.9 CLASSIFICATION ............................................................................................................................ 30
CHAPTER 6 PACKAGING AND ACCESSORIES......................................................... 31
6.1 PACKAGING .................................................................................................................................. 31
6.2 ACCESSORIES ............................................................................................................................... 31
CHAPTER 7 WORKING PRINCIPLE ............................................................................ 32
7.1 HOW TO O BTAIN HIGH QUALITY ECG AND ACCURATE HEART RATE VALUE ....................................... 32
7.2 T HE PRINCIPLE OF NIBP MEASUREMENT ........................................................................................ 32
7.2.1 Points to be noted in NIBP Measurement........................................................................... 33
7.2.2 Clinical Limitations ............................................................................................................... 34
7.3 THE PRINCIPLE OF SPO2/PULSE MEASUREMENT ............................................................................. 34
7.3.1 Working Principle................................................................................................................. 34
7.3.2 Points to be noted in SpO2 and Pulse Measuring............................................................... 35
7.3.3 Clinical Limitations ............................................................................................................... 35
CHAPTER 8 TROUBLESHOOTING.............................................................................. 36
8.1 NO DISPLAY ON THE SCREEN ......................................................................................................... 36
8.2 EXCESSIVE ECG SIGNAL INTERFERENCE OR TOO THICK BASELINE ................................................... 36
8.3 NO BLOOD PRESSURE AND PULSE OXYGEN MEASURES .................................................................. 36
8.4 BLANK PRINTING PAPER ................................................................................................................ 36
8.5 SYSTEM ALARM............................................................................................................................. 36
CHAPTER 9 MAINTENANCE ....................................................................................... 37
-V-
9.1 SERVICE AND EXAMINATION............................................................................................................ 37
9.1.1 Daily Examination ................................................................................................................ 37
9.1.2 Routine Maintenance ........................................................................................................... 37
9.1.3 Battery Maintenance............................................................................................................ 37
9.1.4 Service ................................................................................................................................. 38
9.2 CLEANING, STERILIZATION AND DISINFECTION ................................................................................. 38
9.3 CLEANING, STERILIZATION AND DISINFECTION OF ACCESSORIES ...................................................... 39
9.4 STORAGE ...................................................................................................................................... 39
9.5 TRANSPORTATION ......................................................................................................................... 39
APPENDIX..................................................................................................................... 40
PROMPT INFORMATION EXPLANATIONS .................................................................................................. 40
DEFAULT ALARMING VALUES OF ALL PARAMETERS AND SETUP RANGE ................................................... 41
-VI-
Chapter 1 Overview
1.1 Features
Blood Pressure, SpO2 and Pulse Rate are displayed by big, bright digital LEDs;
ECG waveform, SpO2 plethysmogram and system parameters are displayed on dot
matrix LCD
screen;
Accurate NIBP measurement with hardware and software over-pressure
protection;
Unique SpO 2 measuring technique ensures sensitive and accurate SpO2, Pulse Rate
and Perfusion Index measurement;
HR and SpO2 trend curve display for last 12, 24 or 96 hours;
Up to 400 groups of NIBP measurements can be stored and reviewed by list;
Audible & visible alarm with 3 levels of alarm events;
Nurse call output is available;
With tourniquet function;
NIBP measurement is applicable to adult, pediatric and neonate by patient
selection;
Built-in printer is optional to print out waveforms, and text information.
1.2 Product Name and Model
Name: Vital Signs Monitor
Model: PC-900
1.3 Intended Use
PC-900 Vital Signs Monitor is intended for using in hospitals to monitor patient’s ECG, blood
pressure, SpO2, pulse rate and temperature.
1.4 Conformation
PC-900 Vital Signs Monitor is module designed product, it consists of the main control unit,
ECG/TEMP module (optional), NIBP module (optional), SpO2 measuring module (optional),
printer module (optional), display panel, and power supply block etc. and the related
accessories for ECG, NIBP, SpO2 and Temperature measurement.
According to different needs, you can customize the module configuration by
choosing necessary modules. Therefore, your monitor may not have all the monitoring
functions and accessories.
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1.5 Symbols on the Monitor
Adult Patient
Waveform Freeze
Pediatric Patient
Pulse sync indicator
Neonatal Patient
Setup Menu
NIBP Start/Cancel
AC Power
Alarm Silence
DC Power
Print
Type BF applied part
Up
Type CF applied part with
defibrillator protection
OK
Warning, refer to User Manual.
Down
Equal potential terminal
ECG Lead Selection
Nurse call output
-2-
Chapter 2 Operating Principle
2.1 Overall Structure
The overall structure of the monitor is shown in Fig. 2.1.
Figure 2.1
PC-900 Vital Signs Monitor is module designed product; it consists of ECG/TEMP module
(optional), NIBP module (optional), SpO2 module (optional), main control unit, printer module
(optional), display panel, and power supply block etc.
1.
ECG/TEMP module measures ECG signal and detects heart rate with ECG lead wires and
electrodes, it also measures temperature with temperature probe.
2.
The SpO2 module detects and calculates pulse rate and oxygen saturation (SpO2), and
provides plethysmogram and perfusion index as well.
3.
The NIBP module performs the measurement of blood pressure by non-invasive way of
oscillometric technology, including the diastolic, systolic and mean arterial pressure. The
cuffs are designed for adult, pediatric and neonate respectively.
4.
The main control unit is in charge of LED and LCD display, keyboard input, data storage,
printing, and networking function.
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Chapter 3 Installation and Connection
3.1 Appearance
3.1.1 Front Panel
Figure 3.1 Front panel illustration
Description:
1
Alarm indicator
Indicator
Alarm Event
Alarm Level
Red flashing
High priority alarm
Exceeding the limits, low battery voltage
Orange
Medium priority alarm
Leads or probe off
Green light
Normal
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2
SYS: display systolic pressure value
3
DIA: display diastolic pressure value.
4
MAP: Display mean arterial pressure or measuring time of the latest group of NIBP
measurement; they will be displayed alternately. The format of NIBP measuring time is
“hh:mm”. If the tourniquet is in use, the cuff pressure will be diplayed here.
Note: two formats to display NIBP value: “×××mmHg” and “××.×kPa”. Refer to section “4.4.2
NIBP Setup” to set the unit of NIBP value; the conversion relation between “mmHg” and
“kPa”: 1mmHg=0.133kPa.
5
HR(priority indicator): if HR indicator is on, it indicates that the numerical value beside is
HR measuring value;
6
Display HR or PR value: when the set of “Setup Menu
System priority” is “HR”, it
shows HR value here preferentially; if the set is “PR”, PR value will be shown preferentially.
7
PR(priority indicator): if PR indicator is on, it indicates that the numerical value beside is
pulse rate value; Unit: “bpm (beats per minute)”.
8
SpO2: Display SpO2 value; Unit: “%”
9
“ ”: Bar-graph of pulse intensity
10 LCD panel
11 Pulse sync indicatoratient category indicator: “
” for adult; “ ” for pediatric; “
” for
neonate; Patient category is selected under sub-menu “Patient Info” within the setup
menu.
12 Pulse sync indicator: Cardio-pulse/pulse sync indicator. When HR priority indicator is on,
its flashing is synchronized with heart beat; When PR priority indicator is on, its flashing is
synchronized with pulse.
13
NIBP: start/cancel NIBP measurement
14
Alarm silence key: Enable/disable alarm silence function. When the alarm silence
indicator on the left of keys is on, it means the system is in alarm silence status and it lasts
this status for 2 minutes. When finishing counting down, the system will resume normal
alarm status automatically, if alarm event occurs at this time the alarm sound will be
effective again.
15 Alarm silence indicator: When it is on, it indicates that the monitor stays in alarm silence
status.
16
Print: the internal printer is optional, press this key to print the current measuring
data;
17 Up: shift cursor forward/upward
18 OK: to confirm selection or modification
-5-
19 Down: shift cursor backward/downward
Display: shift LCD display modes
20
21
22
Waveform Freeze: freeze the current displayed waveform.
ECG Lead Selection: select ECG leads among I, II, III, aVR, aVL, aVF and V.
23 : AC Power indicator
: DC Power indicator
24
AC Power
indicator
DC Power indicator
Descriptions
ON (green)
ON (green)
this device is using mains power supply
ON (green)
ON (orange)
OFF
ON (green)
Status
OFF
ON (green)
25
this device is using mains power supply
and the battery is being recharged.
the battery is being used
the battery is being used, but battery
ON (orange, blinking) voltage is low, the beeper also gives
warning.
the battery is being recharged while the
OFF
device is off
: Power button: Press power button for 3 seconds to start the monitor or shut off the
monitor.
Note: Short time pressing power button for entering the Power Saving Mode screen, then
according to your need to make the device stay in the power saving mode or exit from power
saving mode (this function is optional and needs hardware support).
26 SpO2: SpO2 sensor connector
27 NIBP: NIBP hose connector
28 TEMP: TEMP probe connector
29 ECG: ECG cable connector
3.1.2 Side Panel
The built-in thermal printer is in the left panel. It is easy for user to print waveform and data.
-6-
3.1.3 Rear Panel
Figure 3.2 Rear Panel
Introduction to the rear panel:
1 Handle
2
Fan
3
Nameplate
4
“FUSE T3.15 A”: Fuse holder. Fuse specification: T3.15AL/250V 520mm.
5
“AC100~250V” : AC power supply socket
6
Loudspeaker
7
Mounting hole for hanging the monitor
8
NET: serial communication port which is used to network with central monitoring system
(optional);
9
10
Nurse-call connector
: Equipotential ground terminal
-7-
3.2 Installation
3.2.1 Opening the Package and Check
1. Open the package, take out the monitor accessories from the box carefully and place it in
a safe stable and easy to watch position.
2. Open the accompanying document to sort the accessories according to the packing list.
Inspect the monitor for any mechanical damages
Check all the accessories for any scratch or deformity, especially on connector, wire
and probe parts
If in doubt, please contact the local dealer or our company in case of any problems. We are
to offer you the best solution for your satisfaction.
3.2.2 Connecting the Power Supply
1. When powered by AC mains power supply:
Make sure that the AC mains power supply is within 100-250VAC with 50Hz or 60Hz.
Use the power cord provided by the manufacturer. Insert one end of it to the power
port of the monitor and the other end to the single-phase mains power outlet with
protected earth.
Caution: if necessary, make the monitor grounded properly by the provided
grounding wire.
2. When powered by built-in battery
Install battery: refer to Chapter 3.3.5 Battery Installation.
Caution: it’s better to recharge the battery after it is used up, the charging time
should be 13~15 hours long.
3.2.3 Starting the Monitor
The system performs self-test and enters initial display after switching on the monitor, and the
orange alarm indicator blinks to inform that the user can begin operating it.
Check all the applicable functions to make sure that the monitor works normally.
If the battery is applied please recharge it after using the monitor to ensure sufficient
power storage.
Do not use the device to monitor the patient if there are indications of damage or reminders of
error. Please contact the local dealer or our company.
It’s recommended to delay 1 minute to start it again.
-8-
3.3 Sensor Placement and Connection
3.3.1 ECG Cable Connection
ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the
patient and the lead. The lead connects the monitor. The locations of the electrodes are very
important for obtaining accurate ECG signals.
1. Connect the cable to the right-panel connector marked with the ECG icon.
2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid
variations in electrical resistance. For ECG monitoring, it is strongly recommended to use
silver/silver chloride electrodes. When dissimilar metals are used for different electrodes,
the electrodes may be subject to large offset potentials due to polarization. Using
dissimilar metals may also increase recovery time after defibrillation.
3. Prepare the electrode sites according to the electrode manufacturer’s instructions.
The locations of the electrode are in the following Figure:
Figure 3.3 Electrode Location
Note: If skin rash or other unusual symptoms develop, remove electrodes from patient.
4. After starting the monitor, if the electrodes become loose or disconnected during
monitoring, the system will display “LEAD OFF” on the screen to alarm the operator.
It might not display ECG wave with 3 leads. The 5 leads should be used to
have ECG wave.
5. The ECG leads and their corresponding locations are as follows:
Symbol
Position
The intersection between the centerline of the right
RA
clavicle and Rib 2
The intersection between the centerline of the left
LA
clavicle and Rib 2
LL
Left part of the upper abdomen
RL
Right part of the upper abdomen
C (V)
C1(V1)
Chest
C2(V2)
-9-
electrode
C3 (V3) The electrodes are placed in different places, the
C4 (V4) different lead forms will display.
C5 (V5)
C6 (V6)
Table 3-1
Safety Instructions for ECG Monitoring
Use the same type electrode on a patient. If skin rash or other unusual symptom occurs,
remove electrodes from patient. Do not attach electrodes on the patient with an
inflammation of the skin or scores on skin.
PC-900 Vital Signs Monitor can only be equipped with ECG leads provided by our
company; using ECG leads supplied by other companies may cause improper
performance or poor protection while using defibrillator.
Electric parts of electrodes, leads and cable are forbidden to contact any other
conductive parts (including ground).
PC-900 Vital Signs Monitor can resist against defibrillator and electrosurgical unit.
Readings may be inaccurate for a short time after or during using defibrillator or
electrosurgical unit.
Transient caused by cable circuitry blocks while monitoring may be similar to the real
heartbeat waveform, as a result resistance heart rate alarm rings. If you put the electrodes
and cable in proper places according to this manual’s instructions and the instructions for
using electrode, the chance of this transient occurring will be decreased.
To the patient with pacemaker, due to that this device has been designed to provide
resistance to pacemaker signal interference, generally the pacemaker pulse is not
counted in heart rate measurement and calculation, but when the cycle time of
pacemaker pulse is over 2ms, it may be counted. In order to reduce this possibility,
observe the ECG waveforms on the screen carefully and do NOT rely entirely on the heart
rate display and alarm system of this monitor when monitoring this kind of patients.
Besides the improper connection with electrosurgical unit may cause burns, the monitor
may be damaged or arouse deviations of measurement. You can take some steps to
avoid this situation, such as do NOT use small ECG electrodes, choosing the position
which is far away from the estimated Hertzian waves route, using larger electrosurgical
return electrodes and connecting with the patient properly.
ECG leads may be damaged while using defibrillator. If the leads are used again, please
do the functional check first.
When removing the ECG cable, hold the head of the connector and pull it out.
When the monitor is inoperable due to an overload or saturation of any part of the
ampifier, it will prompt “Lead off” to remind operator.
No predictable hazard will be caused by the summation of leakage currents when several
item of monitor are interconnected.
-10-
3.3.2 Blood Pressure Cuff Connection
1. Select a cuff of appropriate size according to the age of the subject. Its width should be 2/3
of the length of the upper arm. The cuff inflation part should be long enough to permit
wrapping 50-80% of the limb concerned. See the table below for the dimensions:
Arm circumference
Cuff Type
Cuff width
Neonate Cuff
6.0cm9.5cm
3cm
Small-sized Cuff for Pediatric
6cm11cm
4.5cm
Middle-sized Cuff for
10cm19cm
8cm
Large-sized Cuff for
18cm26cm
10.6cm
Adult Cuff
25cm35cm
14cm
Table 3-2
Figure 3.4 Cuff Placement
2. Connect the cable to connector marked with the NIBP icon.
Safety Instructions for NIBP Monitoring
When taking the measurement of a pediatric or neonate’s (less than 10 years old)
blood pressure, do NOT operate in the adult mode. The high inflation pressure may
cause lesion or even body putrescence.
It is recommended to take the blood pressure measurement manually. Automatic
measurement should be used at the presence of a doctor/nurse.
NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or
with sickle cell disease, or partial bleeding will appear.
Pay attention to the color and sensitivity of the limb when measuring NIBP; make
sure the blood circulation is not blocked. If blocked, the limb will discolor, please
stop measuring or remove the cuff to other positions. Doctor should examine this
timely.
Confirm your patient category (adult, pediatric or neonate) before measurement.
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Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion
area, otherwise, damages may be caused to the limbs.
Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure
accurate
measurement.
Do NOT twist the cuff tube or put heavy things on it.
When unplugging the cuff, hold the head of the connector and pull it out.
3.3.3 SpO2 Sensor Connection
SpO2 sensor is a very delicate part. Please follow the steps and procedures in operating it. Failure
to operate it correctly can cause damage to the SpO2 sensor.
Operation procedure:
1.
Connect the SpO2 sensor to the connector labeled “SpO2”. When unplugging the
probe, be sure to hold the head of the connector and pull it out.
2.
If the finger clip SpO2 sensor is used, insert one finger into the sensor (index finger,
middle finger or ring finger with short nail length) as shown in the figure below.
Figure 3.5 Finger clip SpO2 sensor placement
3. If the neonate SpO2 sensor is used, please follow Figure 3.6 to connect.
Sensor adapter: wrapper
Y type sensor
Figure 3. 6 Neonate SpO2 sensor placement
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Safety Introductions for SpO2 Monitoring
Continuous use of finger clip SpO2 sensor may result in discomfort or pain,
especially for those patients with microcirculatory problem. It is recommended that
the sensor should NOT be applied to the same finger for over two hours.
SpO2 measuring position must be examined more carefully for some special patient.
Do NOT place the SpO2 sensor on the finger with edema or fragile tissue.
Please do not allow the cable to be twisted or bended.
Do NOT put the SpO2 sensor and pressure cuff on the same limb, otherwise the NIBP
measuring will affect SpO2 measuring and cause the alarm error.
Using nail polisher or other cosmetic product on the nail may affect the accuracy of
measurement.
The fingernail should be of normal length.
Do NOT use the damaged SpO2 sensor.
The SpO2 sensor can not be immerged into water, liquor or cleanser completely, because
the sensor has no capability of waterproofness.
3.3.4 TEMP Transducer Connection
Connecting methods:
1. Attach the transducers to the patient firmly;
2. Connect the cable to TEMP probe connector in the front panel.
Note: When unplugging the probe, be sure to hold the head of the connector and pull it out.
3.3.5 Loading printing paper
Operation procedures for loading printing paper:
1. Press both “OPEN” notches with force on printer shield with two thumbs to open it.
2. Move the tab of rubber roller lock at the left 90°upwards to unlock it, refer to the
following figure with mark .
3. Cut one end of the paper into triangle, and load the paper from the underside of the
rubber roller.
4. Turn the roller clockwise to get the paper rolled, and put the paper roll into the
compartment.
5. Pull the paper out of paper slot on the shield.
6. Move the tab of the rubber roller lock 90° downwards to lock it.
7. Put the shield back in position and secure it.
Operation procedures for taking out printing paper roll:
1~2 steps are the same with the 1~2 steps mentioned above for loading printing paper.
3. Roll the loading roller anti-clockwise and pull the paper out.
4~5 steps are the same with the 6~7 steps mentioned above for loading printing paper.
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Figure 3.7 Loading and taking out printing paper
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3.3.6 Battery Installation
1. Ensure that the monitor is not connected to AC power supply and the monitor is turned
off.
2. Open the battery cover and place the battery in the direction as shown in Fig. 3.8 to
insert the battery into any one of battery compartments. Do not insert battery with their
polarities reversed.
3. Move the battery baffle to secure battery.
4. Close the battery cover.
Underside view
Figure 3.8 Battery Installation
Note:
Do not insert battery terminal with its polarities reversed, or the monitor can not
be started.
Please take out the battery before transport or storage.
-15-
Chapter 4 Operations
4.1 Initial Monitoring Screen
When the parameter configuration of monitor is “ECG+SpO2+NIBP”, insert the ECG cable into the
socket labeled “ECG” and attach the ECG leads to the electrodes placed on human body, once
powered up, the LCD will display the initial monitoring screen, this is the default display screen as
well.
Figure 4.1 Default Display Screen
If the ECG cable is disconnected from the monitor or leads off from the patient, the ECG waveform
will become a base line in main display area and “Lead off” will appear at the left side of prompt
info area (as shown in Figure 4.2).
Figure 4.2 Lead off
The LCD screen will display the information by different display views, short pressing “
” key to
shift screen display among 4 display views: ECG waveform screen (default screen), SpO2
plethysmogram screen, SpO2 trend graph screen, HR trend graph screen and NIBP list screen.
Long pressing “
” key will enter the setup menu screen. For every display view, the display area
is divided into 3 parts: title area, main display area, and prompt info area (see Figure 4.1). The
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prompt info area contains 3 segment of information: status or event indication at the left, patient ID
number in the middle, real time clock at the right (also see Figure 4.1).
4.1.1 Default Display Screen Description
Title area:
1 ECG lead status and ECG waveform scale.
“ECG”: indicate the current monitoring parameter is ECG.
“36.8 ”: temperature numerical value
Main display area:
When ECG leads is attached on the patient and connected to the monitor well, ECG
waveform will be displayed in the main display area.
Prompt Info:
Status or event indication segment:
This segment will display the ECG leads status, probe status, alarm silence
counting-down timer, automatic NIBP measurement counting-down timer, over limit
warning and other error messages for technical warning. If more than one event occurs or
more status appears, the indication message will be displayed alternately at this segment.
“NIBP C-D: XXX”: the counting-down timer of NIBP measurement is XXX seconds. This
prompt message appears only when the NIBP measuring mode is set as “AUTO X”.
“mute C-D: XXX”: the counting-down timer of alarm silence is XXX seconds. This prompt
message appears only when the alarm silence is enabled.
Patient ID segment:
“03”: Patient ID number.
Real time clock segment:
“11:30:25”: the current time.
4.1.2 Operation Instructions
“
” key: select ECG lead. When ECG is monitored, press this key to switch the ECG
lead among ,, , aVR, aVL, aVF and V.
“
“
“
“
” key: freeze ECG waveform or Plethysmogram on the screen.
” key: shift display mode.
” key: print ECG waveform. Press it again to stop printing.
” key: start/cancel NIBP measurement.
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“
“”/ “”key change ECG waveform scale.
” key: Alarm silence switch, press it to enable/disable alarm silence.
4.2 SpO2 Monitoring Screen
Short time press “
Display” key to shift the screen view to SpO2 monitoring screen, as shown in
Figure 4.3.
Figure 4.3 SpO2 Monitoring Screen
4.2.1 Screen Description
Title area:
“PI: 3‰”: the perfusion index is 3‰; it displays only when “Setup MenuSpO2PI
Display” is set as “ON”.
Note: PI display function is optional and it needs hardware support.
“PLETH”: Mark of SpO2 plethysmogramwhen “PLETH” displays in title area, the main
display area will be SpO2 plethysmogram, and this display screen is the default screen.
“36.8 ”: temperature numerical value
Main display area:
When SpO2 sensor is placed on the patient and connected to the monitor well, a trace of sweeping
waveform (plethysmogram) will be displayed in the main display area (as shown in Figure 4.3).
If the SpO2 sensor is disconnected from the monitor or off from the patient, the plethysmogram will
become a base line in main display area and “Probe off” will appear at the left side of prompt info
area (as shown in Figure 4.4).
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Figure 4.4 Probe Off
4.2.2 Operation Instructions
“
“
” key: Press it to print a trace of SpO2 plethysmogram, press it again to stop
printing.
“
” key: start/cancel NIBP measurement.
“
” key: Alarm silence switch, press it to enable/disable alarm silence.
” key: press this key to shift to next display view (SpO2 trend graph).
4.3 Trend Graph Display
Short pressing “
Display” key to shift the screen view to trend graph display screen, as shown in
Figure 4.5.
Trend graph
Trend length
Figure 4.5 Trend Graph
4.3.1 Screen Description
“12 hours”: the trend length of trend graph; three options: “12”, “24” or “96” hours; when
the selection is 12 hours, the upper trend graph will display SpO2 trend curve for last 12
hours.
“cursor on”: enable the display of cursor on trend graph, i.e. the vertical cursor line
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displayed in trend graph, so the user can move the cursor to inspect the SpO2 value at the
given time.
“SpO2 ”: indicate that the trend graph beside it is SpO2 trend. Let the cursor stay here and
press“
” key to confirm, then press “
” key or “
” key again to select trend graph type:
“SpO2 ”: SpO2 trend graph
“HR” HR trend graph
4.3.2 Operation Instructions
1.
Press “
” key or “
” key to highlight “trend length” or “cursor on” selection.
2.
Press “
” key to confirm.
3.
Press “
” key or “
” key again to select value of trend length (12/24/96 hours) if the
selecting box stays in “trend length” option, or to move the cursor if the selecting box stays
in “cursor on” option.
Instructions for viewing the trend curve:
Select “cursor on” and press “
” key to confirm, and “cursor on” becomes “cursor off” ,
then you can press “ ” key or “ ” key to move the vertical cursor, the list box below will
display SpO2/HR value and the time value at the point where the cursor stays. Move
cursor back and forth this way, you can view the SpO2/HR trend (12/24/96 hours long).
Press “
” key again to exit trend viewing.
When pressing “ ” key or “ ” key to move cursor, the moving step is variable. The rule is
that the initial step is 1 point, after pressing “ ” or “ ” key towards the same direction for
5 times, the step becomes 5 points, and with 5 more pressing the step becomes 10, then
20. No matter what step is, as long as you press “ ” or “ ” key towards the other
direction, the step becomes 1 and towards the other direction.
4. press
“
“
” key: press this key to shift to next display view.
” key: Press it to print the current displayed trend graph.
“
” key: start/cancel NIBP measurement
“
” key: alarm silence switch; press it to enable/disable alarm silence.
4.4 NIBP List Screen
Short pressing “
Display” key to shift the screen to NIBP List screen, as shown in Figure 4.6.
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Figure 4.6 NIBP List
The first column is the date, the second column is NIBP measuring time, the third column is NIBP
value, and the fourth column is pulse rate (measured by NIBP module). “SYS/DIA/MAP” indicates
the value of “systolic pressure/diastolic pressure/mean arterial pressure”.
4.4.1 Operation Instructions
On NIBP List screen, if NIBP measurement is more than 6 groups, press “ ” key or “ ” key to
scroll up or down through all the measurement values. If NIBP measurement is not more than 6
groups, the keys “ ”or “ ” are not effective.
“
“
“
” key: start/cancel measuring NIBP.
“
” key: alarm silence switch; press it to enable/disable alarm silence.
” key: press this key to shift to next display view.
” key: print NIBP list.
4.5 Setup Menu Screen
At any display view screen, long time press “
Display” key to shift the screen to Setup Menu
screen, as shown in Figure 4.7. All the functional parameters of the system can be set through
Setup Menu.
Figure 4.7 Setup Menu Screen
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There are 8 functional groups for setting parameters: “ECG TEMP, SpO2, NIBP, Nurse Call, System,
Patient Info, Date/Time and Default” on the Setup Menu Screen.
1. Press“
” key or “
” key to shift cursor to corresponding functional group setting.
2. Pres “
” key to confirm and enter into corresponding functional parameter setup screen.
” key under the setup menu will print ECG waveform.
3. Pres “
4. Press “
” to exist from Setup Menu Screen.
At Setup Menu Screen or its submenu screen, when pressing “
” key, the default display
screen will be printed.
The following will cover each functional parameter’s setting up.
4.5.1 ECG and Temperature Setup
Figure 4.8 ECG/TEMP Setup Screen
Screen Description:
“Lead”: ECG lead selection: ,,, AVR, AVL, AVF or V;
“Gain”: ECG waveform scale:
“×1/2”- waveform reduced to half of nominal scale
“×1”- nominal waveform scale
“×2”- waveform with doubled scale
“1mV”: generating internal 1mV calibration signal. This signal is used to test the function of
the machine. It is not used during normal operation. The default set is off.
“HR
”: HR alarm switch; “” indicates HR alarm is on; “
“HR
Hi/Lo”: high/low limit of HR alarm;
“TEMP
” indicates HR alarm is off.
”: temperature alarm switch; “” indicates temperature alarm is on; “
”
indicates temperature alarm is off.
“TEMP
Hi/Lo”: high/low limit of temperature alarm;
“Unit”: body temperature unit. Two options: “” or “”. Conversion relation: 1= (X1.8)
+32.
“T probe”: the type of temperature probe “KRK”;
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4.5.2 SpO2 Setup
Figure 4.9 SpO2 Setup Screen
Screen Description:
“SpO2 ”: SpO2 alarm switch; “” indicates SpO 2 alarm is on; “
is off.
” indicates SpO2 alarm
“SpO2 Hi”: high limit of SpO2 alarm; range: “1~100”.
“SpO2 Lo”: low limit of SpO2 alarm; range: “0~99”.
”: pulse rate alarm switch; “” indicates PR alarm is on; “
“PR
is off.
” indicates PR alarm
“PR Hi”: high limit of PR alarm; range: “22~250”.
“PR Lo”: low limit of SpO2 alarm; range: “0~248”.
“PI display”: “on” means PI display is enabled; “off” means PI display is disabled.
Operation Instructions
1. Press “
” key or “
2. Press “
” key to confirm and active this parameter setting.
3. Press “
” key or “
4. Press “
”key again to confirm and save the setting.
5. Press “
” key to move cursor to select parameter.
” again to adjust or modify parameter value.
” key to return to upper level screen.
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4.5.3 NIBP Setup
Figure 4.10A NIBP Setup
Figure 4.10B Tourniquet
Setup
NIBP Setup Screen Description:
“SYS ”: systolic pressure alarm switch; “” indicates systolic pressure alarm is on;
“
” indicates systolic pressure alarm is off.
“SYS Hi”: high limit of systolic pressure alarm; range: “32~250” mmHg.
“SYS Lo”: low limit of systolic pressure alarm; range: “30~248” mmHg.
“DIA ”: diastolic pressure alarm switch; “” indicates diastolic pressure alarm is on;
“
” indicates systolic pressure alarm is off.
“DIA Hi”: high limit of diastolic pressure alarm; range: “22~230” mmHg.
“DIA Lo”: low limit of diastolic pressure alarm; range: “20~228” mmHg.
“MAP ”: mean arterial pressure alarm switch; “” indicates mean arterial pressure
alarm is on; “
” indicates mean arterial pressure alarm is off.
“MAP Hi”: high limit of mean arterial pressure alarm; range: “28~242” mmHg.
“MAP Lo”: low limit of mean arterial pressure alarm; range: “26~240” mmHg.
“Mode”: NIBP measuring mode, “manual”, “AUTO 1”, “AUTO 2”, …“AUTO 240” and
“STAT”
etc. options. “AUTO 1” means NIBP measurement takes once every one minute
automatically; “AUTO 60” means NIBP measurement takes once every 60 minutes
automatically; In AUTO mode, the counting-down timer is displayed in the “Prompt Info”
area, as shown in Figure 4.1.
“unit”: unit of the blood pressure value;
“mmHg” or “kPa” can be selected. Conversion: 1kPa=7.5mmHg.
“>>”: Page down icon. When cursor stays in the “unit” filed, press “ ” key to enter
Tourniquet
Setup.
Tourniquet Setup Screen Description:
“Pressure”: when you use Tourniquet function, you need to preset a cuff pressure for
hemostasia. The pressure is adjustable, and its adjusting limit is different for different
patient category:
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for neonates: preset range: 70~100mmHg, default value: “90” mmHg;
for infants: preset range: 80~130 mmHg, default value: “110” mmHg;
for adults: preset range: 80~180mmHg, default value: “140” mmHg.
If the pressure drops down slowly under 10mmHg compared with the preset value due to
little air leakage in the pneumatic system when time passes by, the monitor will re-inflate
to maintain the cuff pressure close to the preset pressure value.
Note: the unit of cuff pressure is the same with the NIBP unit in NIBP Setup.
“Duration”: After presetting the cuff pressure, you need to set the time period for
maintaining the preset pressure after inflation. “5, 6, 7,…120” minutes adjustable. The
default value is “40” minutes.
If the set value is “xx” minutes, the monitor will count down from “xx” minutes
automatically when starting cuff inflation. When time is up, it will deflate automatically.
“Alert T”: the alert time for reminding user that the operation of tourniquet is going to be
end after this time period. 1 to 60 minutes adjusting range with 1 minute step, the default
value is “5” minutes. If the set value is “xx” minutes, the monitor will produce alarm sound
until ending deflation when counting down time reaches to “xx” minutes. The alarm type is
high priority alarm. (For example: the duration is 40 minutes, the alert time is 5 minutes, the
alarm will ring for prompt when the duration counting down to 5 minutes. The Prompt Info
area starts to prompt: TOUR C-D 300 seconds. )
“Start”: shift cursor to “Start” and press “ ” key, “Start” becomes “Stop” and meanwhile
the blood cuff starts being inflated; Pressing “Stop” button can stop using this function.
After deflation, it will change to “Start” again.
4.5.4 Nurse Call
Figure 4.11 Nurse Call Setup Screen
Screen Description:
“Output level”: two options “low” or “high” output levels are available.
When the calling system in hospital works in “Normal Open” mode, “low level” should be
selected.
When the calling system in hospital works in “Normal Close” mode, “high level” should be
selected
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“Source”: three kinds of alarm sources can trig the nurse call: high level alarm, medium level
alarm and low level alarm (multi-optional). If you don’t make choice, nurse call signal will not
be sent out.
“Duration”: two options “pulse” or “continuous” output modes are available;
“continuous”: the continuous mode of output means the nurse call signal will keep until
the selected alarm source(es) disappear, i.e. the signal will last from starting alarm to
stopping alarm.
“pulse”: the output nurse call signal is pulse signal which lasts for 1 second. When several
alarms occur at the same time, only one pulse signal will be sent out.
Note:
Nurse Call function can not be regarded as main alarm notice method, please do not
entirely relay on it. You should combine parameter values with alarm level and
patient’s clinical behavior and symptom to determine patient’s status.
4.5.5 System Setup
Figure 4.12 System Setup Screen
Screen Description:
“Vol”: set beeper volume, “0~7” level adjustable, the set “0” i.e. no sound.
“key beep”: to turn on/off key beep;
“LANG”: language selection. “ENG” for English.
“priority”: priority of “PR” value or “HR” value display. The default set is “HR”.
“backlite”: turn on/off backlight;
“contrast”: adjust LCD display contrast, “0~31” level adjustable;
“care mode”: “Demo” shows the demo waveforms and data. In the demo state, all the
signals and data are generated from the monitor for demonstration and testing purpose.
“Real” shows the real time waveform, i.e. normal monitoring status;
BT SD: turn on/off the pulse beeping sound.
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4.5.6 Patient Info
Figure 4.13 Patient Info Screen
Screen Description:
“ID”: change or set current patient’s ID number, 0~100 adjustable;
“category”: change or set the category of current patient; three options “adult”,
“pediatric” and “neonate”, the default is “adult”.
Note: If the patient ID is changed, all the history data will be cleared, that means SpO2 trend
graph, HR trend graph and NIBP list will become empty.
4.5.7 Date/Time
Figure 4.14 Data/Time Setup Screen
Screen Description:
“yy 07
mm 09
dd 21”: date setting, “07-09-21” shows the date is September 21st , 2007.
“hh 10
mm 15
ss 20”: time setting, “092021” shows the time is10:15:20.
4.5.8 Recover Default Settings
On Setup Menu screen, press “” button or “” button to shift cursor to “Default”, and then press
“” button, all the setting parameters will be reset to factory default setting value.
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4.6 Power Saving Mode
On the initial display screen, you can make the monitor stay in power saving mode for power
saving. Short time press power button to shift screen to “Power Saving Mode” display screen,
as shown in Figure 4.12.
Figure 4.12 Power Saving Mode
Press “” button or “” button to shift cursor to “yes” or “no” and press “” button to confirm. If
your selection is “yes”, all the numerical values displayed on digital LEDs display become darker
and the monitor stays in power saving mode.
Short time press power button again to shift screen to “Power Saving Mode” display screen for
exiting the sleeping mode.
Chapter 5 Technical Specifications
5.1 ECG Monitoring
1. Input signals range in amplitude: ±(0.4mVp ~ 5mVp)
2. Heart rate display range: 20bpm~300bpm
3. Heart rate display accuracy: ±1% or ±2bpm, whichever is greater.
4. Heart rate alarm delay time: ≤10s
5. Sensitivity selection:
×1/2,
5mm/mV
tolerance: ±5%
×1,
10mm/mV
tolerance: ±5%
×2,
20mm/mv
tolerance: ±5%
6. Sweeping speed: 25mm/s
tolerance: ±10%
7. ECG noise level: ≤30μVP-P.
8. ECG input loop current: ≤0.1μA
9. Differential input impedance: ≥5MΩ
10. Common-mode rejection ratio (CMRR): ≥89dB
11. Time constant ≥0.3s
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12. Frequency response: 0.5 Hz40Hz(
,
)
5.2 TEMP Monitoring
1. TEMP measuring range: 25.0~45.0
2. TEMP measuring accuracy: ±0.2
3. TEMP responding time: ≤150s
5.3 NIBP Monitoring
1. Measuring method: Oscillometric Technique
2. Pneumatic pressure measuring range: 0 mmHg~300mmHg
3. Accuracy of pressure measurement: ±3 mmHg
4. Cuff inflation time: <10 seconds (typical adult cuff)
5. Measurement time on the average: < 90 seconds
6. Air release time while the measurement is canceled: <2 seconds (typical adult cuff)
7. Initial cuff inflation pressure
Adult: <180 mmHg;
Infant: <120 mmHg;
Neonate: <90 mmHg
8. Overpressure protection limit
Adult: 300 mmHg; Infan: 240mmHg; Neonate: 150 mmHg
9. NIBP measurement range:
pressunit
SYS
mmHg
MAP
mmHg
DIA
mmHg
Adult
40~255
20~215
10~195
Infant
40~200
20~165
10~150
Neonate
40~135
20~110
10~95
10. NIBP accuracy:
Maximum mean error: ±5 mmHg
Maximum Standard deviation: 8 mmHg
11. Measurement mode: Manual, Auto, STAT
5.4 SpO2 Monitoring
1. Transducer: dual-wavelength LED
2. SpO2 measuring range: 35%~100%
3. Low perfusion capability: 0.4%~5%
4. SpO2 measuring accuracy:
50%~100%
3%
*NOTE: Accuracy of SpO2 should be the root-mean-square(rms) of difference.
5.5 Pulse Monitoring
1. Pulse rate measuring range: 30bpm~240bpm
2. Pulse rate measurement accuracy: ±2bpm or ±2%, whichever is greater.
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5.6 Data Recording
1. Sensitivity selection tolerance: ±5%
2. Recording speed: 25mm/s
5.7 Other Technical Specifications
1. AC power supply voltage: 100~250VAC
2. AC power frequency: 50/60 Hz
3. Fuse specification: T3.15AL/250V 520mm.
4. Internal power supply: 12VDC (rechargeable)
5. Battery specification: 12V 2.3AH(sealed lead-acid battery)
5.8 Operating Environment
Working Environment
Ambient temperature range: 5°C ~ 40°C
Relative humidity: 30 ~ 80%
Atmospheric pressure: 70kPa ~106kPa
Transport and Storage Environment
Ambient temperature range: -20°C ~ 60°C
Relative humidity: 10 ~ 95%
Atmospheric pressure: 50.0kPa ~107.4kPa
5.9 Classification
Safety standard
IEC 60601-1
The type of protection against electric shock
Classequipment.
The degree of protection against electric
h k
Type BF, CF applied parts
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Chapter 6 Packaging and Accessories
6.1 Packaging
The product is packed in high quality corrugated cartons with foam inside to protect the equipment
against damage in the shipping and handling process.
Weight: Details see the indication on the outer package.
Dimension: 360(L)×320(W)×410(H) (mm)
6.2 Accessories
(1) ECG cable with lead wire
One set
(2) ECG electrodes
20 pieces
(3) NIBP cuff
One piece
(4) SpO2 probe
One piece
(5) Temperature probe
One piece
(6) Power cord
One piece
(7) Grounding wire
One piece
(8) User manual
One copy
(9) Quality Certificate
One copy
(10) Warranty
Two copies
(11) Packing list
Two copies
Note: The accessories are subject to change. Detailed items and quantity see the Packing
List.
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Chapter 7 Working Principle
7.1 How to Obtain High Quality ECG and Accurate Heart
Rate Value
The electrocardiogram (ECG or EKG) is primarily a tool for evaluating the electrical events within the
heart. The action potentials of cardiac-muscle cells can be viewed as batteries that cause charge to
move throughout the body fluids. These currents represent the sum of the action potentials occurring
simultaneously in many individual cells and can be detected by recording electrodes at the surface of
the skin. The figure below shows the system of the heart.
First of all, the hospital should be equipped with a 100~250V power supply system with a typical
grounding wire. If big interference in ECG continues, connect one end of the grounding wire provided
with this equipment to the grounding wire on the back panel of this monitor, and the other end to the
special grounding wire, water pipe or radiator.
A common ECG plate electrode used together with this monitor has short shelf life. Generally, the
shelf life is only one month after the package is opened. When outdated plate electrode is used, due
to skin’s contact impedance and big electrode potential, the chance of interference will be increased,
and the ECG baseline will have an unstable inclination. Therefore, always use valid plate electrodes.
7.2 The Principle of NIBP Measurement
Blood pressure may be measured in an invasive way (whereby the sensor will be inserted into
blood vessel directly) or a non-invasive way. The non-invasive way includes several
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methodologies, such as the Korotkoff Sound Method and oscillating method. The Korotkoff Sound
Method is used as a conventional way, whereby stethoscope is used to measure the blood
pressure. By the oscillating method, an inflation pump will fill the air, and release it slowly. A
computer will record change of the cuff pressure when the air is released. With this record, the
blood pressure value will be determined. First of all, make sure the signal quality judgment by
computer meets the requirements of accurate calculation (such as sudden limb movement or cuff
being hit during the measurement). If the answer is negative, give up the calculation. If the answer
is positive, proceed with calculation of the blood pressure value.
As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher
than that of human ears, the oscillating method uses different definitions for measurement of
diastolic pressure, mean arterial pressure and systolic pressure from the Korotkoff Sound Method.
When the oscillating method is used, the circuit in the measuring apparatus will separate the
amplitude of the cuff pressure from its change with pulsation. With the oscillating method, the
blood pressure at the maximum amplitude of cuff pressure is defined as the mean arterial
pressure. The blood pressure at amplitude of cuff pressure forward reduced according to proper
proportion is defined as systolic pressure, while the blood pressure at amplitude of cuff pressure
backward reduced according to proper proportion is defined as diastolic pressure. The maximum
change of pulse pressure occurs at these two points. They are equivalent to the point with pulse
sound and the point without pulse sound respectively in the Korotkoff Sound Method.
When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive
monitoring method shall be used.
7.2.1 Points to be noted in NIBP Measurement
Like common non-invasive blood pressure measurement, improper operation may cause
inaccurate or blank result or misunderstanding of the measuring information when the oscillating
method is used to take the measure of blood pressure. This point needs particular attention of the
operators.
1. Requirements of the cuff:
1) Appropriate cuff should be selected according to the age of the subject.
2) Remember to empty the residual air in the cuff before the measurement is commenced.
3) Locate the cuff in such a way that the “” mark is at a location where the clearest pulsation
of brachial artery is observed.
4) The cuff should be tightened to a degree where insertion of one finger is allowed.
5) The lower end of the cuff should be 2cm above the elbow joint.
2. The subject should lie on the back so that the cuff and the heart are in a horizontal position
and the most accurate measure is taken. Other postures may lead to inaccurate
measurement.
3. Do not speak or move before or during the measurement. Care should be taken so that the
cuff will not be hit or touched by other objects.
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4. The measures should be taken at appropriate intervals. Continuous measurement at too short
intervals may lead to pressed arm, reduced blood flow and lower blood pressure, and
resulting inaccurate measure of blood pressure. It is recommended the measure be taken at
intervals of more than two minutes.
5. With the oscillating method, when blood pressure is measured, the inflation pressure of the
cuff will be automatically adjusted according to the previous measure. Generally, the initial
inflation pressure is 180mmHg (for the adult mode) or 100mmHg (for the pediatric mode) or 80
mmHg (for the neonate mode) when it is powered on. Following that, 50mmHg (for the adult
mode) or 30mmHg (for pediatric mode) or 10mmHg (for the neonate mode) will be added on
the basis of the last measurement of systolic pressure. In this way, when the blood pressure
rises or the subject is changed, the blood pressure meter may fail in giving the result after the
first-time inflation. This monitor will automatically adjust the inflation pressure until the
measure is taken, after that, up to four measures will be allowed.
6. When an adult subject is monitored, the machine may fail in giving the blood pressure
measure if the pediatric or neonate mode is selected.
7.2.2 Clinical Limitations
1.
Serious angiospasm, vasoconstriction, or too weak pulse.
2.
When extremely low or high heart rate or serious arrhythmia of the subject occurs.
Especially auricular fibrillation will lead to unreliable or impossible measurement.
3.
Do not take the measurement when the subject is connected with an artificial heart-lung
machine.
4.
Do not take the measurement when the subject uses diuresis or vasodilator.
5.
When the subject is suffering from major hemorrhage, hypovolemic shock and other
conditions with rapid blood pressure change or when the subject has too low body
temperature, the reading will not be reliable, for reduced peripheral blood flow will lead to
reduced arterial pulsation.
6.
Subject with hyperadiposis;
7.3 The Principle of SpO2/Pulse Measurement
7.3.1 Working Principle
This monitor measures the pulse oxygen saturation (SpO2) and pulse by means of the radiograph
of infrared light and the red light emitted by LED through body’s peripheral areas (such as fingers),
whereby the photoelectric detecting circuits will analyze the absorptivity of the oxyhemoglobin and
reduced hemoglobin respectively, and give the photoabsorption rates before and after pulsation.
Using the measure of photoabsorption change due to pulsatory arterial blood flow caused by
PLETH waveform, the SpO2 can be obtained.
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7.3.2 Points to be noted in SpO2 and Pulse Measuring
1. The finger should be properly placed (see the attached illustration of this instruction
manual), or else it may cause inaccurate measurement result.
2. Make sure that capillary arterial vessel beneath the finger is penetrated through by red and
infrared lights.
3. The SpO2 sensor should not be used at a location or limb tied with arterial or blood
pressure cuff or receiving intravenous injection.
4. Do not fix the SpO2 sensor with adhesive tape, or else it may result in venous pulsation
and consequential inaccurate measurement result of SpO2.
5. Make sure the optical path is free from any optical obstacles like adhesive tape.
6. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual
ruby light, infrared heater, and direct sunlight etc.
7. Strenuous action of the subject or extreme electrosurgical interference may also affect the
accuracy.
8. Please do not use the SpO2 sensor when having the MRI, or burn may be caused by
faradism.
7.3.3 Clinical Limitations
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood stream
of subject is required. For a subject with weak pulse due to shock, low ambient/body
temperature, major bleeding, or use of vascular contracting drug, the SpO2 waveform
(PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
2. For those with a substantial amount of staining dilution drug (such as methylene blue,
indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine
(Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the SpO2
determination by this monitor may be inaccurate.
3. The drugs such as dopamine, procaine, prilocaine, lidocaine and butacaine may also be a
major factor blamed for serious error of SpO2 measurements.
4. As the SpO2 value serves as a reference value for judgement of anemic anoxia and toxic
anoxia, the measurement result of some patients with serious anemia may also present as
good SpO2 value.
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Chapter 8 Troubleshooting
8.1 No Display on the Screen
Shut down the machine and unplug the power. Use a universal meter to check if the outlet has
proper voltage, if the power cable is in good condition, and if the power cable is properly
connected with this apparatus or outlet. Remove the fuse from the back cover of this machine, and
make sure it is in good condition.
8.2 Excessive ECG Signal Interference or Too Thick Baseline
1.
Check if the plate electrodes are properly located, and if valid plate electrodes are used.
2.
Check whether the lead wires are inserted properly. If no ECG curve is displayed, check if
the ECG lead wires are broken.
3.
Make sure the mains outlet has standard grounding wire.
4.
Check if the grounding wire of the apparatus is properly grounded.
8.3 No Blood Pressure and Pulse Oxygen Measures
1.
Check if the blood pressure cuff is properly wrapped around the arm according to the
operating instructions, if the cuff leaks, and if the inlet is closely connected with the NIBP
jack on the side panel. Check if the indicator of the pulse oxygen probe flashes and if the
pulse oxygen probe is properly connected to the SpO2 jack on the side panel.
2.
If the problems still exist, please contact the local dealer.
8.4 Blank Printing Paper
1. Check whether the printing paper is installed with its face reversed. Please reinstall it and
let the sensitive page face upward.
2.
If the problems still exist, please contact the local dealer.
8.5 System Alarm
1.
When the parameter value is higher or lower than the alarm limits, the alarm will ring.
Please check whether the alarm limit value is proper or the condition of the patient.
2.
Probe off. Please check the connection of the probes.
Note: In case of trouble of this machine in the service, follow the instructions below to
eliminate the problem first. If the attempt fails, contact the dealer in your local area or the
manufacturer. Do not open the cabinet without permission.
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Chapter 9 Maintenance
9.1 Service and Examination
9.1.1 Daily Examination
Before using the monitor, the checks below should be carried out:
Check the monitor for any mechanical damage;
Inspect the exposed parts and the inserted parts of all the leads, and the accessories;
Examine all the functions of the monitor that are likely to be used for patient monitoring,
and ensure that it is in good working condition;
Make sure that the monitor is grounded properly.
Pay close attention to the fluctuation of the local power supply voltage. A manostat is
recommended when necessary.
In case any indication of damage about the function of the monitor is detected and
proven, it is not allowed to apply it to the patient for any monitoring.
9.1.2 Routine Maintenance
After each maintenance or the yearly maintenance, the monitor can be thoroughly inspected by
qualified personnel, including function and safety examinations.
If the hospital fails to carry out a satisfactory maintenance program about the
monitor, it may get disabled and harm the patient’s safety and health.
In case of ECG leads damage or aging, please replace the lead.
If there is any indication of cable and transducer damage or they deteriorate, they are
prohibited from any further use.
The adjustable units in the monitor such as potentiometer are not allowed to adjust
without permission to avoid unnecessary failures that affect normal application.
9.1.3 Battery Maintenance
Please pay attention to the polarity of battery, do NOT insert it into battery
compartment with reversed polarities;
Do NOT use the batteries manufactured by other companies, if being inserted, the
device will may be damaged;
In order to avoid damaging the battery, do NOT use other power supply device to
charge the battery;
-37-
After battery ageing phenomenon occurring, to avoid explosion risk do NOT throw
the battery into fire.
Do not hit or strike it with force;
Do not use this battery on other devices;
Do not use this battery below -10 or above 40 ;
Dispose of the battery, the local law should be followed.
It is recommended to use the battery once a month to ensure its strong power
supply capacity and long service life, and recharge it after running out of the power.
In order to maintain battery supply time and prolong battery lifetime, please use the
battery once a month and do not charge it until it is used up each time.
Note: 1. when battery is used to supply power, user should not charge the battery until the low
battery alarm rings. (After line-haul or long-time storing, using battery may not start
the monitor, please charge the battery.)
2. The battery should be charged for 10 to 15 hours.
9.1.4 Service
If the monitor has functional malfunction or is not working, please contact the local dealer or our
company, and we are to offer the best solution as soon as possible for your satisfaction. Only
qualified service engineer specified by the manufacture can perform the service. Users are not
permitted to repair it by themselves.
9.2 Cleaning, Sterilization and Disinfection
Kept the monitor from dust.
It is recommended to clean the outer shell and screen of the monitor to keep it clean. Only
non-corrosive cleanser such as clear water is permitted.
Use the cloth with alcohol to wipe the surface of the monitor and transducers, and dry it
with dry and clean cloth or simply air-dry.
The monitor can be sterilized and disinfected, please clean it first.
Switch off the monitor and disconnect the power cable before cleaning.
Do not let the liquid cleanser flow into the connector jack of the monitor to avoid
damage.
Clean the exterior of the connector only.
Dilute the cleanser.
Do not let any liquid flow into the shell or any parts of the monitor.
Do not let the cleanser and disinfectant stay on its surface.
Do not perform high pressure sterilization to the monitor.
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Do not put any parts of the monitor in the liquid.
Do not pour the disinfector on its surface while sterilization.
9.3 Cleaning, Sterilization and Disinfection of Accessories
It is recommended to use a cloth dampened with isopropyl alcohol 70%, a 10% aqueous solution
of sodium hypochlorite (bleach), a 2% gluteraldegyde solution, ammonia, mild soap or disinfectant
spray cleaner to clean the accessories (including sensor, ECG cable and plugs).
Do not use damaged accessories.
Accessories can not be entirely immerged into water, liquor or cleanser.
Do not use radial, steam or epoxyethane to disinfect accessories.
9.4 Storage
If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging,
which shall be kept in a dry and good ventilation place free from dust and corrosive gases.
9.5 Transportation
This monitor should be transported by land (vehicle or railway) or air in accordance with the
contractual terms. Do not hit or drop it with force.
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Appendix
Prompt information explanations
Mute C-D: XXX seconds
Alarm silence count down: XXX seconds
NIBP C-D: XXX seconds
NIBP auto measuring cycle count down: XXX seconds
TOUR C-D: XXX
Tourniquet alert count down: XXX seconds
Probe off
SpO2 probe fells off
PR over limit
PR value exceeds the high/low alarm limit
SpO2 over limit
SpO2 value exceeds the high/low alarm limit
SYS over limit
Systolic pressure value exceeds the high/low alarm limit
DIA over limit
Diastolic pressure value exceeds the high/low alarm limit
MAP over limit
MAP value exceeds the high/low alarm limit
NIBP error 1#
Sensor or other hardware error
NIBP error 2#
Very weak signal because of the cuff, or the patient has very weak
NIBP error 3#
Blood pressure amplifier overflow due to excessive movement
NIBP error 4#
Leaking during the pneumatic device testing
Cuff error
Cuff is not wrapped correctly, or is not connected
NIBP error 5#
Abnormal condition of CPU, such as register overflow, divided by
Air leak
Air moving part, tube or the cuff leak air
NIBP over range
The measurement range exceeds 255mmHg (for neonates: over 135
Over motion
Over pressure
NIBP timeout
The repeated measurement due to moving, excessive noise during
the stepping inflation and measuring pressure and pulse, e.g. during
patient shaking motion
Cuff press exceeds the safety limit value of software. Limit value for
adult: 290mmHg; Limit value for pediatric: 145mmHg;
Or caused by cuff extrusion or flapping cuff with force.
Adult measurement is more than 120 seconds, neonate
measurement is more
h 90
d
-40-
Default Alarming Values of All Parameters and Setup Range
Mode
Alarm range
Parameter
HR
SYS
SpO2
Pulse rate
TEMP
Pediatric
Neonate
(21~250) bpm
180bpm
200bpm
220bpm
Low
(20~249) bpm
40bpm
50bpm
50bpm
High
32~250
H
30~248
180mmHg
130mmHg
110mmHg
60mmHg
50mmHg
50mmHg
H
22~232
H
20~230
120mmHg
90mmHg
90mmHg
50mmHg
40mmHg
30mmHg
160mmHg
110mmHg
100mmHg
Low
H
28~242
H
26~240
50mmHg
40mmHg
30mmHg
High
H
1%~100%
100%
100%
100%
Low
0%~99%
90%
85%
85%
High
(22~250) bpm
180bpm
200bpm
220bpm
Low
(20~248) bpm
40bpm
50bpm
50bpm
High
24.1~46.0
39.0
39.0
39.0
Low
24.0~45.9
34.0
34.0
34.0
Low
Low
High
MAP
Adult
High
High
DIA
Default
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Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a
specific recycling point for electric and electronic equipment. For further
information on recycling points contact the local authorities, the local
recycling center or the shop where the product was purchased. If the
equipment is not disposed of correctly, fines or penalties may be applied in accordance with the national legislation and regulations.
GIMA WARRANTY CONDITIONS
Congratulations for purchasing a GIMA product. This product meets high qualitative standards
both as regards the material and the production. The warranty is valid for 12 months from the
date of supply of GIMA. During the period of validity of the warranty, GIMA will repair
and/or replace free of charge all the defected parts due to production reasons. Labor costs and
personnel traveling expenses and packaging not included. All components subject to wear are
not included in the warranty.The repair or replacement performed during the warranty period
shall not extend the warranty. The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original spare parts, defects caused by negligence or incorrect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software
due to outside agents such as: voltage changes, electro-magnetic fields, radio interferences,
etc. The warranty is void if the above regulations are not observed and if the serial code (if available) has been removed, cancelled or changed. The defected products must be returned only to
the dealer the product was purchased from. Products sent to GIMA will be rejected.
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